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Completed

NCT Number: NCT06033963

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Undergoing Carotid EndArterectomy

The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis undergoing carotid endarterectomy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

In this study, 100 patients with carotid artery stenosis undergoing carotid endarterectomy are included in our center in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 1 year to evaluate the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis undergoing carotid endarterectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18 years, <80 years, regardless of sex;
  • Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 50% (Based on North American Symptomatic Carotid Endarterectomy Trial Collaborators (NASCET) Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
  • Baseline mRS 0-2;
  • Can cooperate with and complete brain magnetic resonance imaging (MRI) examination;
  • Signed and dated informed consent is obtained;

Exclusion criteria

  • Evolving stroke;
  • Chronic complete occlusion of the carotid artery without obvious symptoms of cerebral ischemia;
  • Severe dementia;
  • The causes of cardiogenic embolism, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombosis or valve tumor, congestive heart failure, bacterial endocarditis, etc;
  • Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment);
  • Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine >265umol/l (3mg/dl));
  • The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
  • Pregnant or lactating women;
  • He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
  • Other conditions that the researchers think are not suitable for the group.

Treatment and study plan

Remote Ischemic conditioning

Procedure

Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.

Sham remote ischemic conditioning

Procedure

Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.

Primary outcomes

  1. Proportion of patients who got ≥1 new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

    Time frame: 6 days

    Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.

Secondary outcomes

  1. The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

    Time frame: 6 days

    Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.

  2. The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

    Time frame: 6 days

    Patients underwent magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.

  3. Number of patients with cerebrovascular events, cardiovascular events or death.

    Time frame: 1 year

    Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.

  4. Proportion of patients with any side effects of Remote ischemic conditioning (RIC) treatment.

    Time frame: 6 days

    The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications and Carotid Endarterectomy (CEA).

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Official study title

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Undergoing Carotid EndArterectomy: A Pilot, Randomized Controlled Trial

Acronym: SERIC-CASCEA

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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